UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048505
Receipt number R000055275
Scientific Title Trial of music therapy for the subjects
Date of disclosure of the study information 2022/08/01
Last modified on 2024/01/28 10:02:38

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Basic information

Public title

Study of music therapy in Integrative Medicine

Acronym

Performance and evaluation of music therapy

Scientific Title

Trial of music therapy for the subjects

Scientific Title:Acronym

Trial of music therapy

Region

Japan


Condition

Condition

Healthy and various diseases

Classification by specialty

Medicine in general Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clinical effect of music

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

QOL, ADL, vitals, markers of five senses and several factors related to music and medicine (baseline and 12 weeks later, evaluated factors include various biomarkers)

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjectives with no remarkable problems of QOL/ADL

Key exclusion criteria

Subjectives with remarkable problems of QOL/ADL

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Bando

Organization

Medical research

Division name

Medical and music division

Zip code

7700943

Address

Nakashowa 1-61, Tokushima, Japan

TEL

09031872485

Email

pianomed@bronze.ocn.ne.jp


Public contact

Name of contact person

1st name HIROSHI
Middle name
Last name BANDO

Organization

Medical research/Tokushima Univ

Division name

Medical and music division

Zip code

770

Address

Nakashowa 1-61, Tokushima 770-0943 JAPAN

TEL

819031872485

Homepage URL


Email

pianomed@bronze.ocn.ne.jp


Sponsor or person

Institute

Medical research

Institute

Department

Personal name



Funding Source

Organization

Medical research

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical research

Address

Nakashowa 1-61, Tokushima, Japan

Tel

09031872485

Email

pianomed@bronze.ocn.ne.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2022 Year 08 Month 15 Day

Date of IRB

2022 Year 11 Month 25 Day

Anticipated trial start date

2023 Year 01 Month 25 Day

Last follow-up date

2025 Year 01 Month 25 Day

Date of closure to data entry

2025 Year 04 Month 25 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Collaboration with other research of music therapy and medical practice


Management information

Registered date

2022 Year 07 Month 28 Day

Last modified on

2024 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055275